- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00537160
Diet and Exercise in Overweight Children Postburn
October 25, 2012 updated by: Michele Gottschlich, Shriners Hospitals for Children
The Impact of a Diet and Exercise Program in Overweight Pediatric Patients During Burn Rehabilitation
Examine clinical results of an interdisciplinary weight management program that includes medical evaluation, nutrition counseling, exercise, and behavioral interventions.
Study Overview
Status
Withdrawn
Intervention / Treatment
Study Type
Interventional
Phase
- Early Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 10-18 years old
- BMI > or = 95th percentile
- > 1 year postburn and out of pressure garments
- Live within 100 minle radius of SHC
- Informed consent and HIPPA form signed
- Parent/guardia willing to make time commitment
Exclusion Criteria:
- Undergone major surgery in the 4 months prior to start of program or have any major surgery planned in 2 year time frame
- Physical/health condition that precludes regular exercise
- Significant mental health diagnosis
- Advised by MD not to exercise
- Thyroid disease, routine steroid use,pregnancy
- Unable to understand the instructions/content of program
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
BMI
Time Frame: 12 and 24 months following intervention
|
12 and 24 months following intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
fitness level
Time Frame: 12 and 24 months following intervention
|
12 and 24 months following intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michele M Gottschlich, PhD, RD, CNSD, Shriners Hospital for Children
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2006
Primary Completion (Actual)
October 1, 2012
Study Completion (Actual)
October 1, 2012
Study Registration Dates
First Submitted
September 27, 2007
First Submitted That Met QC Criteria
September 27, 2007
First Posted (Estimate)
September 28, 2007
Study Record Updates
Last Update Posted (Estimate)
October 29, 2012
Last Update Submitted That Met QC Criteria
October 25, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-04-26-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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